my.bionity.com
With an accout for my.bionity.com you can always see everything at a glance – and you can configure your own website and individual newsletter.
25-09-2006: Jerini AG announced the results of its two pivotal Phase III trials (FAST-1 and FAST-2) for the subcutaneous treatment of hereditary angioedema (HAE). In the FAST-2 study, the primary endpoint was reached, showing a significant reduction in the time to onset of symptom relief. While FAST-1 results were clinically relevant, the primary endpoint was not reached. A supportive analysis combining both studies showed a significant reduction in the time to onset of symptom relief. Secondary endpoints, such as patient and physician reported time to first improvement of symptoms, and the time to almost complete relief of symptoms showed highly significant results in favor of Icatibant. Based on the clinically relevant and consistent results of the two trials, the company intends to apply as planned for expedited reviews by the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) starting submission at year-end 2006, with potential launch in 2007.
Icatibant, a synthetic peptidomimetic, works by blocking the B2 receptor as an antagonist to the peptide-hormone bradykinin. Bradykinin has been shown to be elevated in HAE patients and responsible for edema formation during HAE attacks. Icatibant has been granted orphan drug status for the treatment of angioedema by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), potentially securing, upon approval, market exclusivity for seven and ten years, respectively. In addition, the FDA has granted fast-track designation to Icatibant in the indication HAE.
Watchlist
This is where you can add this news to your personal favourites
Jerini AG to Wind Down its Preclinical Programs
Jerini AG has decided to end all negotiations regarding the transfer of assets associated with Jerini AG's preclinical programs and to terminate the employees associated with these programs. The decision was taken following unsuccessful efforts to find an investor for the sale of the precl ... more
Jerini AG Reaches Agreement to Sell JPT Peptide Technologies GmbH to TheraCode GmbH
Jerini AG has reached an agreement to sell its wholly-owned subsidiary, JPT Peptide Technologies GmbH to TheraCode GmbH, Mainz, a wholly-owned subsidiary of BioNTech AG, Mainz. Under the terms of the agreement, TheraCode GmbH will pay Jerini AG a purchase price of approximately € 5 million ... more
Strategic Review of Jerini Assets Completed
Jerini AG and Shire Deutschland Investments GmbH have completed the strategic review of the assets and programs of Jerini AG, not related to Icatibant (Firazyr®), as referred to in the Offer Document published by Shire Deutschland Investments GmbH on August 13, 2008. The Jerini Supervisory ... more
Jerini is a pharmaceutical company based in Berlin, Germany, focusing on the discovery, development, and commercialization of novel peptide-based drugs. The company pursues disease indications that have limited or no treatment options and has built a drug pipeline composed of its own progr ... more
Epigenomics submits the fourth module to the FDA for Epi proColon
Epigenomics AG announced that it has submitted the fourth and final module of its Premarket Approval (PMA) to the United States Food & Drug Administration (FDA) for its blood-based Epi proColon® test for the detection of colorectal cancer in December 2012 as previously indicated, thereby co ... more
FDA Approves Genzyme’s AUBAGIO (teriflunomide), a Treatment for Relapsing Multiple Sclerosis
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration (FDA) has approved AUBAGIO® (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). AUBAGIO has shown significant efficacy across key measures ... more
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years. Tbo-filgrastim is ... more
U. S. Food and Drug Administration (FDA)
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public hea ... more
The European Medicines Agency (EMA) has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court. These interim rulings were made as part of court cases brought by two pharmaceutic ... more
Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh
Following the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-co ... more
European Medicines Agency publishes 2012 annual report
The European Medicines Agency has published its 2012 annual report. The report highlights the main trends recently observed in the Agency’s activities. For the past few years, the Agency has received a stable number of initial marketing authorisation applications (MAAs) for human medicines, ... more
European Medicines Agency (EMA)
The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. more
Über CHEMIE.DE
CHEMIE.DE Information Service GmbH runs specialist scientific internet portals. The secret to our success? We are familiar with what we publish.
Advertising at CHEMIE.DE
Our advertising formats support you in getting your message across to a clearly defined target audience.
© 1997-2013 CHEMIE.DE Information Service GmbH, All rights reserved
Netmeeting
